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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device orthosis, spondylolisthesis spinal fixation
Product CodeMNH
Regulation Number 888.3070
Device Class 2


Premarket Reviews
ManufacturerDecision
AAXTER CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
ADVANCED MEDICAL TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 1
ALLEZ SPINE, LLC
  SUBSTANTIALLY EQUIVALENT 1
ALLURE SPINE L.L.C.
  SUBSTANTIALLY EQUIVALENT 1
ALPHATEC SPINE, INC.
  SUBSTANTIALLY EQUIVALENT 1
APOLLO SPINE, INC.
  SUBSTANTIALLY EQUIVALENT 1
BK MEDITECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
BM KOREA CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
CANWELL MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
CAPTIVA SPINE
  SUBSTANTIALLY EQUIVALENT 3
CHANGZHOU DEAN MEDICAL INSTRUMENT CO, LTD
  SUBSTANTIALLY EQUIVALENT 1
CHANGZHOU DINGJIAN MEDICAL APPLIANCE CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
CHANGZHOU ORTHMED MEDICAL INSTRUMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
CHIN BONE TECHNIQUE CORP
  SUBSTANTIALLY EQUIVALENT 1
CO-LIGNE AG
  SUBSTANTIALLY EQUIVALENT 1
CORELINK, LLC
  SUBSTANTIALLY EQUIVALENT 1
DIO MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
EVEREST SPINE, LLC
  SUBSTANTIALLY EQUIVALENT 1
EXACTECH, INC.
  SUBSTANTIALLY EQUIVALENT 1
GOLD STANDARD ORTHOPAEDICS, LLC
  SUBSTANTIALLY EQUIVALENT 1
HUNG CHUN BIO-S CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
IMPLANOVA CO. LTD
  SUBSTANTIALLY EQUIVALENT 1
INNOVASIS, INC.
  SUBSTANTIALLY EQUIVALENT 1
INNOVATIVE SURGICAL DESIGNS
  SUBSTANTIALLY EQUIVALENT 1
JIANGSU IDEAL MEDICAL SCIENCE & TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
K2M, INC.
  SUBSTANTIALLY EQUIVALENT 2
KALITEC DIRECT, LLC
  SUBSTANTIALLY EQUIVALENT 2
KOREA BONE BANK CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
KYUNGWON MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
L & K BIOMED CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
L&K BIOMED CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
L&K BIOMED CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
LANX, INC.
  SUBSTANTIALLY EQUIVALENT 1
LDR SPINE USA INC.
  SUBSTANTIALLY EQUIVALENT 1
LSK BIOPARTNERS, INC.
  SUBSTANTIALLY EQUIVALENT 1
MAZOR SURGICAL TECHNOLOGIES LTD.
  SUBSTANTIALLY EQUIVALENT 1
MEDICREA INTERNATIONAL
  SUBSTANTIALLY EQUIVALENT 1
MEDICREA INTERNATIONAL S.A.
  SUBSTANTIALLY EQUIVALENT 1
MEDYSSEY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
NEXUS SPINE, LLC
  SUBSTANTIALLY EQUIVALENT 1
NEXXT SPINE LLC
  SUBSTANTIALLY EQUIVALENT 2
NORM TIBBI URUNLER ITHALAT IHRACAT SANAYI VE TICAR
  SUBSTANTIALLY EQUIVALENT 1
OSSEUS FUSION SYSTEMS, LLC
  SUBSTANTIALLY EQUIVALENT 1
OTIS BIOTECH CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
PARADIGM SPINE, LLC
  SE - WITH LIMITATIONS 1
PIONEER SURGICAL TECHNOLOGY
  SUBSTANTIALLY EQUIVALENT 1
RELIANCE MEDICAL SYSTEMS, LLC
  SUBSTANTIALLY EQUIVALENT 1
RENOVIS SURGICAL TECHNOLOGIES, LLC
  SUBSTANTIALLY EQUIVALENT 1
REPUBLIC SPINE, LLC
  SUBSTANTIALLY EQUIVALENT 1
SANACOR
  SUBSTANTIALLY EQUIVALENT 1
SINTEA PLUSTEK, LLC
  SUBSTANTIALLY EQUIVALENT 1
SOLCO BIOMEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
SPINAL EDGE, LLC
  SUBSTANTIALLY EQUIVALENT 1
SPINAL SOLUTIONS, LLC
  SUBSTANTIALLY EQUIVALENT 1
SPINE WAVE, INC.
  SUBSTANTIALLY EQUIVALENT 3
SPINEART
  SUBSTANTIALLY EQUIVALENT 4
SPINECRAFT LLC
  SUBSTANTIALLY EQUIVALENT 1
SPINEFRONTIER, INC.
  SUBSTANTIALLY EQUIVALENT 3
SPINEVISION, S.A.
  SUBSTANTIALLY EQUIVALENT 1
STRYKER SPINE
  SUBSTANTIALLY EQUIVALENT 1
SUZHOU KANGLI ORTHOPAEDICS INSTRUMENT CO., LTD
  SUBSTANTIALLY EQUIVALENT 2
U & I CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
U&I CORP.
  SUBSTANTIALLY EQUIVALENT 1
U&I CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
ULRICH GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 1
VALOREM SURGICAL
  SUBSTANTIALLY EQUIVALENT 1
WEIGAO ORTHOPAEDIC DEVICE CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
X-SPINE SYSTEMS, INC
  SUBSTANTIALLY EQUIVALENT 1
X-SPINE SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
ZAVATION, LLC
  SUBSTANTIALLY EQUIVALENT 1
ZIMMER SPINE
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 286 286
2015 151 151
2016 216 216
2017 174 174
2018 129 129
2019 403 403
2020 442 442
2021 543 543
2022 266 266
2023 122 122
2024 228 228

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 885 885
Break 538 538
Loose or Intermittent Connection 171 171
Device Slipped 157 157
No Apparent Adverse Event 137 137
Migration 136 136
Fracture 128 128
Mechanical Problem 95 95
Insufficient Information 91 91
Migration or Expulsion of Device 90 90
Device Dislodged or Dislocated 90 90
Unintended Movement 82 82
Material Integrity Problem 78 78
Detachment of Device or Device Component 67 67
Material Deformation 64 64
Appropriate Term/Code Not Available 58 58
Device-Device Incompatibility 57 57
Detachment Of Device Component 49 49
Device Operates Differently Than Expected 44 44
Patient Device Interaction Problem 44 44
Loosening of Implant Not Related to Bone-Ingrowth 40 40
Material Separation 38 38
Material Twisted/Bent 35 35
Use of Device Problem 23 23
Human-Device Interface Problem 19 19
Entrapment of Device 17 17
Difficult to Remove 17 17
Positioning Problem 16 16
Compatibility Problem 14 14
Material Fragmentation 14 14
Mechanical Jam 13 13
Malposition of Device 12 12
Crack 10 10
Bent 9 9
Improper or Incorrect Procedure or Method 9 9
Physical Resistance/Sticking 9 9
Noise, Audible 8 8
Material Protrusion/Extrusion 8 8
Fitting Problem 8 8
Fluid/Blood Leak 8 8
Difficult to Insert 8 8
Product Quality Problem 8 8
Disassembly 6 6
Patient-Device Incompatibility 6 6
Device Handling Problem 6 6
Material Split, Cut or Torn 5 5
Device Inoperable 5 5
Sticking 5 5
Corroded 4 4
Disconnection 4 4
Failure To Adhere Or Bond 4 4
Component Missing 4 4
Dent in Material 4 4
Connection Problem 4 4
Difficult to Advance 4 4
Mechanics Altered 4 4
Manufacturing, Packaging or Shipping Problem 3 3
Inaccurate Information 3 3
Physical Property Issue 3 3
Torn Material 3 3
Device Damaged by Another Device 3 3
Improper Chemical Reaction 3 3
Activation, Positioning or Separation Problem 3 3
Split 3 3
Metal Shedding Debris 3 3
Inadequacy of Device Shape and/or Size 3 3
Misassembled 2 2
Loss of or Failure to Bond 2 2
Component Falling 2 2
Contamination 2 2
Positioning Failure 2 2
Unstable 2 2
Incomplete or Missing Packaging 2 2
Defective Device 2 2
Defective Component 2 2
Structural Problem 2 2
Failure to Align 2 2
Failure to Advance 2 2
Biocompatibility 2 2
Output Problem 2 2
Therapeutic or Diagnostic Output Failure 1 1
Osseointegration Problem 1 1
Device Contaminated During Manufacture or Shipping 1 1
Naturally Worn 1 1
Wrong Label 1 1
Failure to Eject 1 1
Deformation Due to Compressive Stress 1 1
Calibration Problem 1 1
Device Contamination With Biological Material 1 1
Expulsion 1 1
Device Contamination with Chemical or Other Material 1 1
Failure to Obtain Sample 1 1
Device Contamination with Body Fluid 1 1
Dull, Blunt 1 1
Display or Visual Feedback Problem 1 1
Inflation Problem 1 1
Burst Container or Vessel 1 1
Collapse 1 1
Partial Blockage 1 1
Unintended Collision 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Code Available 656 656
Pain 411 411
No Known Impact Or Consequence To Patient 340 340
Insufficient Information 293 293
No Clinical Signs, Symptoms or Conditions 263 263
Failure of Implant 216 216
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 172 172
Injury 172 172
Non-union Bone Fracture 171 171
Unspecified Infection 132 132
No Consequences Or Impact To Patient 101 101
Bone Fracture(s) 90 90
Nerve Damage 82 82
No Information 74 74
Neurological Deficit/Dysfunction 71 71
Post Operative Wound Infection 69 69
Osteolysis 60 60
Unspecified Tissue Injury 50 50
Discomfort 47 47
Hematoma 47 47
Hypoesthesia 44 44
Spinal Column Injury 43 43
Stenosis 39 39
Impaired Healing 33 33
Paralysis 31 31
Cerebrospinal Fluid Leakage 31 31
Dysphagia/ Odynophagia 26 26
Spinal Cord Injury 26 26
Unspecified Nervous System Problem 26 26
Physical Asymmetry 22 22
No Patient Involvement 21 21
Foreign Body In Patient 20 20
Weakness 20 20
Device Embedded In Tissue or Plaque 19 19
Fall 18 18
Death 16 16
Joint Laxity 15 15
Numbness 12 12
Perforation of Vessels 11 11
Hemorrhage/Bleeding 10 10
Reaction 10 10
Neck Pain 9 9
Patient Problem/Medical Problem 9 9
Wound Dehiscence 9 9
Seroma 9 9
Fatigue 8 8
Deformity/ Disfigurement 8 8
Inflammation 7 7
Necrosis 7 7
Thrombosis 7 7
Tissue Damage 6 6
Loss of Range of Motion 6 6
Decreased Sensitivity 6 6
Implant Pain 6 6
Thromboembolism 5 5
Irritation 5 5
Muscular Rigidity 5 5
Hypersensitivity/Allergic reaction 5 5
Ossification 5 5
Abscess 4 4
Incontinence 4 4
Neuropathy 4 4
Skin Irritation 4 4
Limited Mobility Of The Implanted Joint 4 4
Ambulation Difficulties 4 4
Inadequate Pain Relief 3 3
Blood Loss 3 3
Swelling/ Edema 3 3
Not Applicable 3 3
Metal Related Pathology 3 3
Complaint, Ill-Defined 3 3
Toxicity 3 3
Headache 3 3
Nausea 2 2
Itching Sensation 2 2
Laceration(s) 2 2
Bacterial Infection 2 2
Pulmonary Embolism 2 2
Urinary Tract Infection 2 2
Burning Sensation 2 2
Tingling 2 2
Paresis 2 2
Pneumonia 2 2
Stroke/CVA 2 2
Swelling 2 2
Unspecified Musculoskeletal problem 2 2
Intervertebral Disc Compression or Protrusion 2 2
Pseudoaneurysm 2 2
Inadequate Osseointegration 2 2
Test Result 2 2
Depression 2 2
Hernia 2 2
Claudication 1 1
Respiratory Failure 1 1
Sleep Dysfunction 1 1
Peroneal Nerve Palsy 1 1
Joint Dislocation 1 1
Fibrosis 1 1
Dysuria 1 1
Nervous System Injury 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Alphatec Spine, Inc. II Oct-29-2012
2 Amendia, Inc II Dec-22-2016
3 EBI, L.P. III Sep-22-2009
4 Exactech, Inc. II Jul-10-2015
5 Stryker Spine II Sep-16-2009
6 Stryker Spine II Jul-07-2009
7 Synthes USA HQ, Inc. II Mar-11-2013
8 X Spine Systems Inc II Jun-22-2015
9 X Spine Systems Inc II Apr-22-2015
10 X Spine Systems Inc II Aug-19-2009
11 XTANT MEDICAL INC II Apr-27-2017
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